BioCentury
ARTICLE | Clinical News

Aggrastat tirofiban regulatory update

January 14, 2013 8:00 AM UTC

Medicure submitted an sNDA to FDA to expand the label of Aggrastat tirofiban to include a high-dose regimen consisting of an initial bolus of 25 µg/kg Aggrastat and then continued at 0.15 µg/kg/min. The non-peptide Integrin alpha(2b)beta(3) (GPIIb/IIIa) (CD41/CD61) antagonist is already marketed in the U.S. in combination with heparin to treat acute coronary syndrome (ACS), including patients who are to be managed medically and those undergoing percutaneous transluminal angioplasty (PTCA) or atherectomy, at a recommended dose of 0.4 µg/kg/min for 30 minutes and then 0.1 µg/kg/min. Medicure has U.S. rights to the product, while Iroko has rights elsewhere from Merck. ...